http://www.pfizer.ca/en/our_products/products/monograph/179 , p.8. http://www.adverseevents.com/ http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.htm http://drugs.com/triamcinolone/ All 3 medications are approved for topical, intramuscular, skin injections, and joint injections where there is a synovial space. Triamcinolone is specifically contraindicated for epidural and intrathecal use. Not one of the 3, produced under conditions of compounding manufacturing are label approved or field tested and clinically tried for these applications. None are FDA approved.

http://www.pfizer.ca/en/our_products/products/monograph/179

http://www.adverseevents.com *FDA has approved the uses suggested by registered manufacturers labels for these medications but has failed to adopt their language about ‘routes of administration.’ The manufacturers warn against the use of routes of administration other than those for which the drugs have been approved, which would include steroid injections into the epidural AND intrathecal space. By adopting language that prohibits intrathecal injection but omits epidural injection as a route of administration, some may infer that epidural injection falls into a class of ‘joint infections or soft tissue injections.’ Joint injections require a synovial space, not present in the spinal column. Soft tissue injections (intradermal, intramuscular) require a mediating blood supply. While joints are specifically named and targeted on the manufacturer’s labels, FDA’s omission has created a glaring gap in WARN language. (This gap is reflected in WebMD.com which embraces the epidural route of administration for these three steroids despite all three manufacturers precautions against injection into body systems other than intradermal, intramuscular, synovial joint space. Systemic and intravenous routes of administration are not recommended for use. All three manufacturers acknowledge the opportunity for extreme accidentality associated with placement of steroids into the intrathecal space, which can only occur through the route of epidural administration. FDA has failed to universally adopt precautionary language against the use of these medications for epidural steroid injection by any method- Triamcinolone contains the manufacturer’s precautions, yet Depo Medrol (Pfizer/Upjohn) and Betamethasone, do not. Pfizer specifically requested this change in 2002, but FDA failed to incorporate the language. **FDA is not responsible for, and has not approved the use of materials sourced from compounding manufacturers for: intradermal or intralesion injection, intramuscular injection, intraocular injection, epidural route of administration, intrathecal injection, or joint (synovial space) injections. ***FDA does not regulate the treatment decisions of physicians who use registered medications. Physician standards and practices are monitored by the Center for Medicare Services (CMS) Adverse events associated with these medications go largely unreported and unresponded to. There appears to be a large and glaring responsibility and communication gap between FDA’s AERS system, the safe use initiative authority, and CMMS standards, practices and payment authorities.

http://www.cdc.gov/hai/outbreaks/clinicians/casedef_multistate_outbreak.html Probable Case. A person who received a preservative-free methylprednisolone acetate (MPA) injection, with preservative-free MPA that definitely or likely came from one of the following three lots produced by the New England Compounding Center (NECC) [05212012@68, 06292012@26, 08102012@51] , and subsequently developed any of the following: Meningitis 1 of unknown etiology following epidural or paraspinal injection 2 after May 21, 2012; Posterior circulation stroke without a cardioembolic source and without documentation of a normal cerebrospinal fluid (CSF) profile, following epidural or paraspinal injection 2 after May 21, 2012; 3 Osteomyelitis, abscess or other infection (e.g., soft tissue infection) of unknown etiology, in the spinal or paraspinal structures at or near the site of injection following epidural or paraspinal injection2 after May 21, 2012; or Osteomyelitis or worsening inflammatory arthritis of a peripheral joint (e.g., knee, shoulder, or ankle) of unknown etiology diagnosed following joint injection after May 21, 2012. 1 Clinically diagnosed meningitis with one or more of the following symptoms: headache, fever, stiff neck, or photophobia, in addition to a CSF profile showing pleocytosis (&gt;5 white blood cells, adjusting for presence of red blood cells by subtracting 1 white blood cell for every 500 red blood cells present) regardless of glucose or protein levels. 2 Paraspinal injections include, but are not limited to, spinal facet joint injection, sacroiliac joint injection, or spinal or paraspinal nerve root/ganglion block. 3 Patients in this category who do not have any documented CSF results should have a lumbar puncture performed if possible, using a different site than was used for the epidural injection when possible. http://www.cdc.gov/hai/outbreaks/meningitis-map-large.html Confirmed Case. A probable case with evidence (by culture, histopathology, or molecular assay) of a fungal pathogen associated with the clinical syndrome.

Transcript

2.
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The Back Pain
Dilemma in America
• The Institute of Medicine described chronic pain as “the
most under treated problem in America”
• By 2011 state legislatures required physician ownership
of outpatient surgical centers in an attempt to reduce
costs
• Interventional Pain Medicine became big business
without sufficient oversight, competing with other
practice modalities
• Compounding drug manufacturing grew as a result to
meet the demands of this new industry without sufficient
FDA oversight or State control

3.
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Theorizing The Problem
An estimated 14,000 – 16,000 tainted
Steroid Injections (including Epidural
Steroid Injections) were administered
to 14,000 patients from the period of
May 26 through Sept 1, 2012.Meningitis Victim prior to her tainted ESI

5.
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Methylprednisolone Acetate,
Betamethasone & Triamcinolone
• Are known causative agents for injury to the central
nervous system
• Are contraindicated for intrathecal use and other
non-indications due to known adverse events
• Intramuscular & intraarticular administration is
approved for manufacturers operating under
controlled practices, with clinical field trial data
• Produced under any condition, including custom
compounding, these steroids do not meet the safe
use criteria for epidural administration

6.
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Characteristics of These Steroids
• When made “preservative free” by compounding
pharmacies, these steroids have a very short
shelf life and therefore are susceptible to poor
shipping, storage & handling practices
• Depresses immune functions in humans which
allows excessive growth of fungi and bacteria
• In non-muscle tissue, these effects are
exacerbated for extended periods
• Provides a perfect growing medium for fungi and
bacteria
• In the CNS, the body has no efficient way to
overcome these effects

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Percutaneous Procedures Performed
These percutaneous procedures
included injections into the
cervical, thoracic, lumbar spine,
and joints.
Types of injections* included
transforaminal, interlaminar,
caudal, trigger point, and
intrajoint procedures.
In some clinics, this amounted to
a rate of approximately 1
procedure performed every 15
minutes.
*NQF Procedure 0309

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About these Materials
• These injections are administered with corticosteroids of various
types. None have been through the vigorous approval process by the
FDA for epidural administration and are not appropriate for any other
use except intra muscular/articular and/or lesional injection. The FDA
has contraindicated Methylprednisolone Acetate (MPA) for intrathecal
use due to its known neurotoxicity and association with the onset of
Arachnoiditis. However both the intrathecal and epidural routes of
administration list the same severe adverse events in the US
DataSheet but only the intrathecal route is cautioned. In fact the
manufacturers of Depo-Medrol/MPA notified the FDA in 1988 and in
1989 of severe adverse events reported with epidural steroid use
(Upjohn, letters to FDA, 1988 & 1989) and requested warning letters
of notification be sent to all heavy users along with a thorough label
change reflecting strict new warnings for epidural administration.
Their request was denied both times by the FDA.
• In 2011 the FDA granted the makers of Triamcinolone (Kenalog) to
add a black box warning: [NOT FOR EPIDURAL USE]

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How Bad Can Things Go Wrong?
• Investigators wondered why fungus injected in
the spinal region should target the base of the
brain. “The observation of abundant fungi in the
perivascular tissues, but relatively low numbers of
fungi inside blood vessels, suggests migration of
fungus into, rather than out of, vessels at this
location. This supports the hypothesis that
Exserohilum migrates from the lumbar spine to
the brain through the cerebrospinal fluid with
subsequent vascular invasion, rather than
migration through the vasculature.”
– (Jana M. Ritter, DVM, CDC’s Infectious Diseases Pathology Branch)

14.
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$78,447.00 Out Of Pocket costs
to date and now suffers from
Arachnoiditis and intractable
pain.
Meningitis Victim After Her Tainted ESI

18.
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We Refuse to be Invisible
• Reach across the aisle - move compounding
safety legislation forward
• Find all those who have been exposed but
ignored so that they too can be finally diagnosed
& treated
• Create victims funding
• Make adverse event reporting mandatory for
ESI’s
• Stop authorizing public payment for unsafe
medical practices
• Ask FDA and HHS-CMMS to take action on
unsafe epidural steroid injection therapies

21.
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https://www.facebook.com/groups/meningitisoutbreak/
If you are one of the exposed, unfound, untreated, or
undertreated, join us at this web address so we can help you
move toward diagnosis & treatment